NMPA published the “Management for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings” on July 19, 2024. It green lights the urgent importation and use of medical devices nationwide even if they have not been approved by NMPA.
The management requirements define the product and medical institution scope, clarify the responsibilities of institutions, enterprises, foreign manufacturers, and agents, and specify application materials, procedures, review methods, and timelines. They apply to the temporary importation of Class II and Class III medical devices urgently needed for clinical use, already available abroad but not domestically, excluding large-scale equipment.
Only leading high-level medical institutions with extensive experience in treating complex, critical conditions and top-tier specialty departments can use these devices. Medical teams must include senior experts to ensure the quality and safety of device usage and patient care.
For the detailed requirements on medical institutes and application materials, please email us at info@ChinaMedDevice.com.
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Key Highlights of the Document
1. Scope and Definition
These requirements apply to the temporary importation and use of Class II and Class III medical devices that are urgently needed in clinical settings. These devices must be approved in foreign countries but not yet approved in China, excluding those that subject to large-scale medical equipment configuration licensing. Clinical urgency is defined as the necessity to prevent or treat life-threatening diseases when no effective domestic treatment or prevention methods are available. Comparable products refer to those already registered domestically with equivalent basic principles, structural composition, main raw materials, production processes, performance requirements, safety evaluations, compliance with national/industry standards, and intended use/application scope.
2. Eligible Medical Institutions
Only Tier 3 Grade A hospitals that meet specified requirements can use the medical devices.
3. Responsibility and Agreements
Medical institutions must take responsibility for the clinical use and management of urgently needed medical devices. A quality agreement/entrustment agreement must be signed between the medical institution, medical device business enterprises, and the foreign manufacturer or their agent. This agreement should clearly outline the quality and safety obligations and responsibilities of each party, including compensation obligations and responsibilities.
4. Application Process
Medical institutions seeking to temporarily import medical devices due to clinical urgency must submit the following application materials to the National Medical Products Administration (NMPA):
- Application form
- Relevant medical device information
- Necessity assessment for the use of the medical device
- Feasibility assessment for the use of the medical device
- Supporting documents
- Letter of commitment
The medical institution must ensure that the submitted materials are legal, truthful, accurate, complete, and traceable. Detailed application requirements and instructions are in Attachment 2.
5. Review and Approval
Upon receipt of the application materials, the NMPA will organize technical review departments and experts to review whether the medical device in question is approved abroad but not yet domestically. The NMPA will also assess the medical institution’s management capabilities, the clinical urgency of the device, and the reasonableness of the quantity needed. Expert groups, consisting of an odd number of members (at least seven), will conduct the review through meetings, document reviews, or written opinions. The group leader will lead the discussion, and personnel from relevant departments such as the drug regulatory department and health administration department can attend the review meetings. The time taken for expert review does not count towards the total review time.
6. Decision Making
If an expert review is conducted, the NMPA will decide within three working days after receiving the written expert opinions whether to allow the temporary importation and use of the device. If approved, the decision will be issued in the form of a comprehensive letter from the NMPA and copied to the National Health Commission, the provincial drug regulatory department, and the provincial health administration department where the medical institution is located. If not approved, the medical institution will be notified in writing.
7. Ethics and Patient Consent
The use of medical devices by medical institutions must be reviewed and approved by the institution’s ethics committee. Additionally, relevant documents such as informed consent forms must be signed by the patient or their guardian in accordance with national regulations.
8. Record Keeping
Medical records generated from the use of these medical devices must be preserved for 30 years, while other relevant data and materials should be kept indefinitely.
9. Incident Reporting
If a serious adverse event directly related to the medical device occurs or if quality and safety hazards are discovered during use, the medical institution must immediately cease using the device.
10. Data Analysis and Reporting
Medical institutions must analyze clinical data, assess risks, and evaluate the safety and effectiveness of the device usage. An annual report on the evaluation of the temporary import and use of the device must be submitted to the provincial drug regulatory department, which will inform the equivalent health administration department.
11. Subsequent Applications
If further use or an increase in the quantity of the medical device is needed for other patients due to clinical urgency, the medical institution must reapply following the same procedures and obtain approval before use.
12. Procurement and Customs Clearance
Medical institutions must procure the medical devices through medical device business enterprises. These enterprises can apply for a one-time customs clearance for the import of the device using the NMPA’s reply letter.
13. Cost and Charges
Charges for the temporary import and use of urgently needed medical devices are to be executed according to the relevant regulations of the medical security department.
14. Provincial and Municipal Authorization
Provincial, autonomous regional, and municipal governments authorized by the State Council to temporarily import and use urgently needed medical devices must conduct their work in accordance with relevant regulations.
